The following data is part of a premarket notification filed by Sutter Biomedical, Inc. with the FDA for Sutter Cpm 9000 -nonmeasuring Exercise Equipment.
| Device ID | K850274 |
| 510k Number | K850274 |
| Device Name: | SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT |
| Classification | Exerciser, Powered |
| Applicant | SUTTER BIOMEDICAL, INC. 3940 RUFFIN RD. San Diego, CA 92123 |
| Contact | Allan H Mizoguchi |
| Correspondent | Allan H Mizoguchi SUTTER BIOMEDICAL, INC. 3940 RUFFIN RD. San Diego, CA 92123 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-23 |
| Decision Date | 1985-04-25 |